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| ID | Type | Description | Link |
|---|---|---|---|
| 1ZIDES102465 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients.
All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily.
Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days.
Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMW-HA | Active Comparator | HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) |
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| placebo | Placebo Comparator | 5 ml of saline via nebulizer b.i.d. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMW-HA | Drug | Aerolized administration b.i.d. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative time on oxygen | cumulative duration of oxygen treatment | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need for advanced airway intervention or death due to COVID19; | need of intubation or death due to COVID19 | 10 days |
| Rate of change of respiratory rate; | rapidity of decrease of respiratory rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele Antonelli Incalzi, MD | Università Campus-Biomedico di Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Biomedico di Roma | Roma | 00128 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 10 days |
| Change in PaO2 /FiO2 ratio during treatment | improvement of PaO2/FiO2 ratio after 10 days of treatment | 10 days |
| Time to discharge from hospital | decrease of cumulative days of hospitalization | 10 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |